OPTICLEAR
FDA 510(k) clearance K842485 · decided 1984-08-10
Clearance details
- K-number
- K842485
- Device name
- OPTICLEAR
- Applicant
- Gelman Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-25
- Decision date
- 1984-08-10
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- JJN
- Device class
- 1
- Regulation number
- 862.2485
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| POWER SUPPLY (K924021) | The Binding Site, Ltd. | 1993-01-28 |
| ELECTROPHORESIS TANK (K924020) | The Binding Site, Ltd. | 1992-12-28 |
| ELECTR-TRANSBLOTTER (K882344) | The W.E.P. Co. | 1989-01-13 |
| REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 (K881852) | Helena Laboratories | 1988-07-08 |
| HELENA REP GEL PROCESSOR (K882163) | Helena Laboratories | 1988-06-20 |
| RAPID ELECTROPHORESIS SYSTEM (REP) (K873352) | Helena Laboratories | 1987-09-08 |
| STAVIP 3000 (K864436) | Roseburg SA | 1987-03-16 |
| ELECTROPHORESIS WORK CENTER (EWC) (K861414) | Helena Laboratories | 1986-08-26 |
| ISOGEL AGAROSE (K841407) | Fmc Corp. | 1985-07-16 |
| EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD (K844710) | Logos Scientific, Inc. | 1985-01-07 |
| OPTIPHOR-10 (K842560) | Gelman Sciences, Inc. | 1984-08-10 |
| ELVI 70 SAFETY CHAMBER (K841804) | Logos Scientific, Inc. | 1984-05-31 |
Recalls involving this device
No recalls on record reference this clearance.